Co-Crystals for Generic Pharmaceuticals: An Outlook on Solid Oral Dosage Formulations.

Maniyam Arun Pandian Rajendran, Ravikiran Allada, Syed Shahnawaz Sajid
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引用次数: 8

Abstract

Co-crystal is an attractive alternative and a new class of solid forms because that can be engineered to have desired physicochemical properties. Co-crystals have gained considerable attention from the generic pharmaceutical industry after the USFDA released its finalized guidlines in the year 2018 on the regulatory classification of co-crystals. In this review, we discussed how co-crystals could be explored as a potential alternative solid form for the development of a generic product that meets the legal, regulatory, and bioequivalence requirements. In the contents, we discussed in detail concepts such as the selection of coformers, various ways of making co-crystals, the strategy of characterization to discriminate between co-crystal and salt, polymorphism in co-crystals, the aspects of intellectual property and, finally, the regulatory aspects of co-crystals.

仿制药的共晶:固体口服剂量制剂的展望。
共晶是一种有吸引力的替代品,也是一种新型的固体形式,因为它可以被设计成具有理想的物理化学性质。在美国fda于2018年发布了关于共晶监管分类的最终指南后,共晶获得了仿制药行业的相当大的关注。在这篇综述中,我们讨论了如何将共晶作为一种潜在的替代固体形式来开发符合法律、法规和生物等效性要求的通用产品。在内容中,我们详细讨论了一些概念,如共晶的选择、制作共晶的各种方法、区分共晶和盐的表征策略、共晶的多态性、知识产权方面以及共晶的调控方面。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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